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Clinical study of CL2020 in patients with acute respiratory distress syndrome associated with SARS-CoV-2 infection

Clinical study of CL2020 in patients with acute respiratory distress syndrome associated with SARS-CoV-2 infection - Clinical study of CL2020 in patients with acute respiratory distress syndrome associated with SARS-CoV-2 infection

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2043210005
Enrollment
43
Registered
2021-04-21
Start date
2021-04-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute respiratory distress syndrome

Interventions

Single intravenous administration

Sponsors

Fukushima Tatsunobu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -SARS-CoV-2 positive patients by RT-PCR -Patients diagnosed with ARDS by Berlin definition -Patients who are intubated and under mechanical ventilatory control

Exclusion criteria

Exclusion criteria: -Patients managed by Extracorporeal Membrane Oxygenation (ECMO) or using ventilation techniques such as High Frequency Oscillatory Ventilation (HFOV) -Patients who are not expected to survive for about 72 hours

Design outcomes

Primary

MeasureTime frame
STEP 1 : Safety as measured by incidence of Adverse events (AEs), adverse drug reactions (ADRs) STEP 2 : Efficacy as measured by mortality up to 4 weeks after administration

Contacts

Public ContactCall center

Life Science Institute, Inc.

lsii.chiken-inq@eppharmaline.co.jp+81-3-6748-7200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026